FDA Device recall Z-1403-2022
RayStation 9B SP1. For radiation treatment planning
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of RayStation 9B SP1. For radiation treatment planning by Raysearch Laboratories Ab, citing an issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1403-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-01 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation 9B SP1. For radiation treatment planning.
Reason
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
Identifiers
| code_info | UDI-DI: 0735000201029720200310 Build number 9.2.0.483 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1403-2022%22
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